Label: ORAL B NEUTRA FOAM MINT MENTHE- sodium fluoride solution

  • NDC Code(s): 0273-0348-06
  • Packager: YOUNG DENTAL MANUFACTURING CO 1, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 13, 2023

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  • Descrption

    Oral-B Neutra-Foam ® is a mint flavored neutral aqueous foaming solution of 2.0% w/w sodium fluoride.

  • Inactives

    Purified water,poloxamer 407, cocamidoprophylbetaine, xylitol, sucralose, flavors.

  • Indication and Usage

    A topically applied foaming solution to aid in the prevention of dental caries.

  • Warnings

    In theevent more than the treatment dose isswallowed, administer calcium (e.g.milk) and get medical help or contact aPoison Control Center right away. Avoidspraying towards open flame. Contentsunder pressure. Do not puncture orincinerate. Do not expose to heat. Storeat temperatures between 59-86°F(15-30°C). Keep from freezing.

  • Package Label

    Product Label

    Product Label

  • INGREDIENTS AND APPEARANCE
    ORAL B NEUTRA FOAM   MINT MENTHE
    sodium fluoride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-0348
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0273-0348-06165 g in 1 TUBE; Type 0: Not a Combination Product10/08/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/08/2015
    Labeler - YOUNG DENTAL MANUFACTURING CO 1, LLC (006309355)
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